1. The Field of the Invention
The present invention relates to methods and systems for processing fluids, namely, biological fluids.
2. The Relevant Technology
The biopharmaceutical industry uses a broad range of mixing systems for a variety of processes such as in the preparation of media and buffers and in the growing of cells and microorganisms in bioreactors. Many conventional mixing systems, including bioreactors, comprise a rigid tank that can be sealed closed. A drive shaft with impeller is rotatably disposed within the tank. The impeller functions to suspend and mix the components.
In many cases, great care must be taken to sterilize and maintain the sterility of the mixing system so that the culture or other product does not become contaminated. Accordingly, between the production of different batches, the mixing tank, mixer, and all other reusable components that contact the processed material must be carefully cleaned to avoid any cross contamination. The cleaning of the structural components is labor intensive, time consuming, and costly. For example, the cleaning can require the use of chemical cleaners such as sodium hydroxide and may require steam sterilization as well. The use of chemical cleaners has the additional challenge of being relatively dangerous, and cleaning agents can be difficult and/or expensive to dispose of once used.
Furthermore, biological fluids are often produced in bulk at a manufacturing facility and then shipped in smaller quantities to customers for further processing or utilization. This process typically entails manufacturing a fluid through use of a mixing process, dispensing the fluid into a transport container, and then shipping the transport container to a customer. The customer then dispenses the fluid into a further processing container so that the fluid can be remixed or resuspended so that the fluid is homogeneous prior to use. As can be appreciated, this transferring of fluids between different containers can be time consuming, labor intensive and run the risk of breaching sterility.
Accordingly, what is needed are mixing systems that require minimum cleaning or sterilization. What is also needed are systems that that can be used for preparing, transporting, and resuspending solutions that are simple to use and minimize the risk of breaching sterility.